This invention relates to an improved implantable breast prosthesis and, in particular, to an implantable breast prosthesis that may be anchored in place in a body cavity to reduce postoperative movement of the implant and provide an indication of the orientation of the prosthesis.
Breast prostheses are known which are designed to be implanted behind the breast for reconstruction or augmentation of the mammary gland. These prostheses are made up of an elastomeric envelope or shell delimiting a hermetically closed space which is filled with saline solution, silicone gel or other suitable filling material. Typically, a small periareolar, inframammary, transaxillary, or periumbilical incision is made in the patient and a retroglandular or retropectoral pocket is formed into which the breast prosthesis is inserted. The implant is filled with saline solution or other suitable filling material to a specified volume. The physician verifies the correct orientation of the prosthesis before closing the incision.
A postoperative problem may occur if the implant becomes dislodged from its original placement, creating a noticeable breast deformity. This deformity has been detected in women both within the immediate and long-term postoperative period. Additionally, there is currently no means to diagnose whether the implant has become malpositioned at any time after surgery.
Another difficulty with anatomically shaped breast prostheses is correctly orienting the prosthesis once it has been inserted in the retroglandular or retropectoral pocket. Typically a tab is attached to the posterior surface of the prosthesis in the six o'clock position to provide a way for the physician to correctly position the prosthesis within the pocket. However, when a transaxillary incision is used to insert the prosthesis, the surgeon is not able to reach the tab to verify correct placement of the implant and must rely on visual inspection to ensure the proper orientation of the implant.